scholarly journals Effect of Customized Insoles on Gait in Post-Stroke Hemiparetic Individuals: A Randomized Controlled Trial

Biology ◽  
2021 ◽  
Vol 10 (11) ◽  
pp. 1187
Author(s):  
Jie Wang ◽  
Lei Qiao ◽  
Long Yu ◽  
Yanmin Wang ◽  
Redha Taiar ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Stance Phase ◽  
Controlled Trial ◽  
Weight Bearing ◽  
Gait Training ◽  
Secondary Outcome ◽  
Control Group ◽  
Stroke Patients ◽  
Randomized Controlled ◽  
Experimental Group

Background: Insoles have been widely applied to many diseases, but stroke involves complex problems and there is a paucity of research on the application of insoles in stroke patients. Aim: To evaluate the effect of customized insoles on gait in patients with hemiplegia. Design: A randomized controlled trial. Setting: Rehabilitation department of a hospital. Population: A total of 50 stroke patients were randomized into an experimental group (n = 25) or a control group (n = 25). Methods: Both groups received conventional gait training, which was conducted five times a week, every 40 min for four weeks and patients in the experimental group were required to wear customized insoles for at least 1 h per day for four weeks. The primary outcome measure was the Tinetti Gait Scale (TGS) and the secondary outcome measures were the plantar pressure test, 6-min walking test (6MWT), lower extremity Fugl–Meyer assessment (FMA-LE), Berg Balance Scale (BBS), and the modified Barthel index (MBI). Results: Compared to the control group, there were significant increases in the experimental group after four weeks (p = 0.014) and at the four week follow-up (p = 0.001) in the change in TGS, weight-bearing on the involved side (p = 0.012) or forefoot (p = 0.028) when standing, weight-bearing on the involved side (p = 0.01 6) or forefoot (p = 0.043) when walking, early stance phase (p = 0.023) and mid stance phase (p = 0.013) on the involved side, FMA-LE (p = 0.029), BBS (p = 0.005), and MBI (p = 0.009), but there were no differences in the late stance phase (p = 0.472) on the involved side when walking or in the 6MWT (p = 0.069). Conclusions: Customized insoles had great efficacy in enhancing gait performance in stroke patients.

scholarly journals Effect of Customized Insoles on Gait in Post-stroke Hemiparetic Individuals: A Randomized Controlled Trial

2021 ◽  
Author(s):  
Jie Wang ◽  
Lei Qiao ◽  
Long Yu ◽  
Yanmin Wang ◽  
Ying Zhang ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Stance Phase ◽  
Controlled Trial ◽  
Weight Bearing ◽  
Adjunctive Treatment ◽  
Secondary Outcome ◽  
Control Group ◽  
Clinical Trial Registration ◽  
Randomized Controlled ◽  
Experimental Group

Abstract Background: Insoles were considered to be a beneficial adjunctive treatment option for gait rehabilitation, which could provide a proper basic support for walking. The purpose of this study was to evaluate the effect of customized insoles (Jiangsu Suyun Medical Equipment Co. Ltd, Jiangsu, China) on the gait of patients with hemiplegia.Methods: This randomized controlled trial was set in the rehabilitation department of a hospital. A total of 50 stroke patients were randomized into an experimental group (n=25) or a control group (n=25). Both groups received 40-min conventional gait training, which was conducted 5 times a week, for 4 weeks and patients in the experimental group were required to wear customized insoles for at least 1 h per day for 4 weeks. The primary outcome measure was Tinetti Gait Scale (TGS), which was assessed three times(baseline[T0], 4 weeks from baseline[T1] and 4 weeks after completion of the intervention[T2]), and the secondary outcome measures were the plantar pressure test, 6-min walking test (6MWT), Lower Extremity Fugl-Meyer assessment (FMA-LE), Berg Balance Scale (BBS) and Barthel Index (BI), which was assessed twice(baseline[T0] and 4 weeks from baseline[T1]).Results: Compared to the control group, there were significant increases in the experimental group after 4 weeks(P = 0.014) and 4 weeks follow-up(P = 0.001) in the change of TGS, weight-bearing on the involved side (P = 0.012) or forefoot (P =0.028) when standing, weight-bearing on the involved side (P = 0.016) or forefoot (P = 0.043) when walking, early stance phase (P = 0.023) and mid stance phase (P = 0.013) on the involved side, FMA-LE (P = 0.029), BBS (P = 0.005) and BI (P = 0.009), but no difference in late stance phase (P = 0.472) on the involved side when walking and in the 6MWT (P = 0.069).Conclusions: Customized insoles had great efficacy in enhancing gait performance.Clinical Trial Registration: ChiCTR1900024843.Registered 30 July 2019，http://www.chictr.org.cn/edit.aspx?pid=41003&htm=4.

The effectiveness of a non-guided mindfulness application on perceived stress in a non-clinical Dutch population: a Randomized Controlled Trial (Preprint)

2021 ◽  
Author(s):  
Leonieke W Kranenburg ◽  
Jamie Gillis ◽  
Birgit Mayer ◽  
Witte JG Hoogendijk
Keyword(s):  
Randomized Controlled Trial ◽  
Perceived Stress ◽  
Psychological Symptoms ◽  
Controlled Trial ◽  
Secondary Outcome ◽  
Control Group ◽  
Dutch Population ◽  
Randomized Controlled ◽  
Experimental Group

BACKGROUND Mindfulness has become increasingly popular and positive outcomes have been reported for mindfulness-based interventions (MBIs) to reduce stress. These findings make room for innovative perspectives on how MBIs could be applied, for instance through mHealth. OBJECTIVE The aim of this study is to investigate if a non-guided mindfulness mobile phone application can decrease perceived stress in a non-clinical Dutch population over the course of eight weeks, with follow-up at six months. METHODS A randomized controlled trial (RCT) was performed, comparing the experimental group that made use of a structured 8-week mHealth mindfulness program and a control group after 8 weeks, with follow-up after six months. Participants were recruited via a national television program. The primary outcome measure was perceived stress as measured by the Perceived Stress scale (PSS), secondary outcomes were symptoms of burnout (VAS) and psychological symptoms (measured by the four-dimensional symptom questionnaire ; 4DSQ at follow-up). Outcomes were analyzed using a multilevel regression model. RESULTS At baseline, 587 respondents were included. Results showed no differences between groups for the level of perceived stress. With regard to the secondary outcome measures, the VAS for emotional exhaustion and physical exhaustion showed statistically significant lower scores for the experimental group after 8 weeks (resp. p=.04 and p= .01), but not at follow-up. There were also no differences between groups found for psychological symptoms. CONCLUSIONS These findings do not support our hypothesis that using the mindfulness app would reduce stress levels. However, findings with regard to diminished exhaustion at 8 weeks are encouraging and require further investigation.

Long-term Effectiveness and Adoption of a Cellphone Augmented Reality System for Stroke Rehabilitation: Randomized Controlled Trial (Preprint)

2021 ◽  
Author(s):  
Jie Jia ◽  
Chong Li ◽  
Xinyu Song ◽  
Shugeng Chen ◽  
Chuankai Wang ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Motor Function ◽  
Controlled Trial ◽  
Control Group ◽  
Stroke Patients ◽  
Randomized Controlled ◽  
Augmented Reality System ◽  
Home Based ◽  
Experimental Group

BACKGROUND A serious game-based Cellphone Augmented Reality System (CARS) was developed for rehabilitation of stroke patients, which is portable, convenient, and suitable for self-training. OBJECTIVE The present research aimed to study the effectiveness of CARS in improving upper limb motor function and cognition function of stroke patients via conducting a long-term randomized controlled trial and analyze the patient’s acceptance of the proposed system. METHODS A randomized, double-blind, controlled trial was performed with 30 post-stroke, sub-acute phase patients. All patients in both the experimental group (n=15) and the control group (n=15) performed a 1-hour session of therapy each day, 5 days per week, for 2 weeks. Patients in the experimental group received 30 minutes of rehabilitation training with CARS and 30 minutes of conventional occupational therapy (OT) each session, while patients in the control group received conventional OT for the full 1 hour each session. The Fugl-Meyer Assessment-Upper Extremity subscale (FMA-UE), Action Research Arm Test (ARAT), Manual Muscle Test (MMT), Brunnstrom Stage (BS), and Barthel Index (BI) were used to assess motor function, and the Mini-Mental State Examination (MMSE), Add VS Sub (AVS), and Stroop Game (SG) were used to assess cognitive function before and after the 2-week treatment period. In addition, the User Satisfaction Evaluation Questionnaire (USEQ) was used to reflect the patients’ acceptance of the system in the experimental group after the final intervention. RESULTS All the assessment scores of the experimental group and control group were significantly improved after intervention (p＜0.05). The experimental group’s score of FMA-UE and ARAT increased by 11.47 and 5.86 respectively after intervention, which were both significantly higher than the increase of the control group (p＜0.01). Similarly, the score of AVS and SG in the experimental group increased by 7.53 and 6.83 respectively after the intervention, which was also higher than the control group (p＜0.01). The evaluation of the adoption of this system has three sub-dimensions. In terms of accessibility, the patients reported a mean score of 4.27±0.704 for the enjoyment of their experience with the system, 4.33±0.816 for success to use the system, 4.67±0.617 for the ability to control the system. In terms of comfort, the patients reported 4.40±0.737 for clear information provided by the system, 4.40±0.632 for comfort. In terms of acceptability, the patients reported 4.27±0.884 for usefulness in their rehabilitation, 4.67±0.617 for agreeing with CARS as a suitable tool for home-based rehabilitation. CONCLUSIONS CARS and conventional OT together-based rehabilitation were more effective in improving both upper limb motor function and cognition function as compared with conventional OT. Due to the low cost, and ease of use, CARS is also potentially suitable for home-based rehabilitation. CLINICALTRIAL The Chinese Clinical Trial Registry (ChiCTR1800017568).

scholarly journals Acupuncture for osteoporosis: study protocol for a randomized controlled trial

2020 ◽  
Author(s):  
M Huang ◽  
MX Lai ◽  
XY Wang ◽  
YF Wang ◽  
J Yang ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Secondary Outcome ◽  
Control Group ◽  
Primary Osteoporosis ◽  
Randomized Controlled ◽  
Acupuncture And Moxibustion ◽  
One Year ◽  
Experimental Group

Abstract Background: The rapid increase in the prevalence of osteoporosis and the rate of fractures after osteoporosis indicates that osteoporosis has become a serious global public health problem. A recent meta-analysis showed that oral alendronate and parenteral injection of zoledronate had no statistical significance in preventing postmenopausal hip fractures. Acupuncture and moxibustion are widely used in the treatment of osteoporosis due to their good analgesic effects. Early observation showed that integral adjustment of acupuncture and moxibustion therapy could improve the quality of life of patients with osteoporosis and prevent the occurrence of osteoporosis fractures. As the observation period of fracture is too long, it is necessary to carry out a large and strictly designed multi-center randomized trial covering the risk factors of fracture and fracture induction, so as to evaluate the effectiveness of acupuncture and moxibustion in the treatment of primary osteoporosis.Methods/Design: A multicenter randomized controlled trial will be performed in three hospitals. 312 participants patients within primary osteoporosis will be divided into an experimental group and a control group randomly. The experimental group is treated with acupuncture and western medicine while the control group is treated with Western medicine. All the patients will receive a 3-month treatment and 6-month,and one year follow-ups. The primary outcome is the bone mineral density (BMD), the secondary outcome is Bone-derived alkaline phosphatase(BALP), bone glaprotein(BGP), visual pain scale score(VAS),Traditional Chinese Medicine (TCM) syndrome scores, quality of daily life score(QOL) and adverse events. Outcome measures (including primary and secondary outcome measures) are collected at baseline,3 months of the intervention, Causes and number of falls are collected at 6 months and one year after the intervention.Discussion: This study will provide clinical evidence for the treatment of primary osteoporosis with holistic adjustment acupuncture. This study will evaluate the synergistic effect of acupuncture treatment for primary osteoporosis and provide evidence for clinical treatment.Trial registration: This trial was registed at Chinese Clinical Trial Registry, registration date: 5 August 2018.URL:http://www.chictr.org.cn,registration number:ChiCTR1800017581.

scholarly journals Efficacy and safety of the extracorporeal shock wave therapy in patients with postherpetic neuralgia: study protocol of a randomized controlled trial

2020 ◽  
Author(s):  
Lu Chen ◽  
Ruihao Zhou ◽  
Fuguo Sun ◽  
Yan Weng ◽  
Ling Ye ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Postherpetic Neuralgia ◽  
Controlled Trial ◽  
Interventional Therapy ◽  
Secondary Outcome ◽  
Control Group ◽  
Medication Therapy ◽  
Randomized Controlled ◽  
Self Rating ◽  
Experimental Group

Abstract Background: Postherpetic neuralgia (PHN) is one of the most common chronic neuropathic pain, which seriously affected the quality of the life due to the severity of pain and the poor response to the current treatment. The main management strategies of PHN include medication therapy and invasive interventional therapy. However, there are lots of side effects. It is meaningful to find another effective and safe treatment for PHN. Methods: A single-center, randomized, single-blind clinical trial will be held. A total of 98 participants will be randomly divided into control group and experimental group in a 1:1 ratio. Patients in control group will receive conventional treatment including medication therapy and invasive interventional therapy. The experimental group will be treated with extracorporeal shockwave therapy (ESWT) in addition to conventional therapy. The primary outcome is visual analogue scale (VAS), secondary outcome contains 36-item short-form health survey (SF-36), self-rating anxiety Scale (SAS), self-rating depression scale (SDS) and Pittsburgh sleep quality index (PSQI). Assessors who are blinded to the randomization will collect data during the intervention period at baseline, 1 weeks, 4 weeks, and 12 weeks in this study. The plasma levels of TNF-α、IL-6 in patients will be detected before and after ESWT to explore part of the biochemical mechanism of ESWT for the treatment of PHN. Discussion: This randomized controlled trial will be held to evaluate the actual effectiveness and safety of ESWT in patients with PHN, and thus provide clinical evidences for its application in the PHN management and explore the potential mechanism of this treatment. Trial registration: www.ChiCTR.org.cn, identifier: ChiCTR1900025828. Registered on 10th September 2019.

scholarly journals Chinese Massage Combined with Herbal Ointment for Athletes with Nonspecific Low Back Pain: A Randomized Controlled Trial

2012 ◽  
Vol 2012 ◽  
pp. 1-8 ◽  
Author(s):  
Ling Jun Kong ◽  
Min Fang ◽  
Hong Sheng Zhan ◽  
Wei An Yuan ◽  
Ji Ming Tao ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Low Back Pain ◽  
Back Pain ◽  
Controlled Trial ◽  
Muscle Stiffness ◽  
Secondary Outcome ◽  
Control Group ◽  
Low Back ◽  
Randomized Controlled ◽  
Experimental Group

Non-specific low back pain (NLBP) is an increasing health problem for athletes. This randomized controlled trial was designed to investigate the effects of Chinese massage combined with herbal ointment for NLBP. 110 athletes with NLBP were randomly assigned to experimental group with Chinese massage combined with herbal ointment or control group with simple massage therapy. The primary outcome was pain by Chinese Short Form McGill Pain Questionnaire (C-SFMPQ). The secondary outcome was local muscle stiffness by Myotonometer. After 4 weeks, the experimental group experienced significant improvements in C-SFMPQ and in local muscle stiffness compared with control group (between-group difference in mean change from baseline, −1.24 points,P=0.005in sensory scores; −3.14 points,P<0.001in affective scores; −4.39 points,P<0.001in total scores; −0.64 points,P=0.002in VAS; −1.04 points,P=0.005in local muscle stiffness during relaxation state). The difference remained at one month followup, but it was only significant in affective scores (−2.83 points,P<0.001) at three months followup. No adverse events were observed. These findings suggest that Chinese massage combined with herbal ointment may be a beneficial complementary and alternative therapy for athletes with NLBP.

scholarly journals Does regular strength training cause urinary incontinence in overweight inactive women? A randomized controlled trial

2021 ◽  
Author(s):  
Kari Bø ◽  
Lene Anette H. Haakstad ◽  
Gøran Paulsen ◽  
Anne Mette Rustaden
Keyword(s):  
Randomized Controlled Trial ◽  
Urinary Incontinence ◽  
Strength Training ◽  
Short Form ◽  
Controlled Trial ◽  
Secondary Outcome ◽  
Control Group ◽  
Randomized Controlled ◽  
Sum Score ◽  
New Onset

Abstract Introduction and hypothesis Urinary incontinence (UI) is common in women who exercise. We aimed to investigate new onset UI in formerly inactive, overweight or obese women (BMI > 25) participating in three different strength training modalities compared with a non-exercising control group. Methods This was a secondary analysis of an assessor blinded randomized controlled trial investigating the effect of 12 weeks of three strength training concepts for women on muscle strength and body composition. None of the programs included pelvic floor muscle training. International Consensus on Incontinence Questionnaire Urinary Incontinence Short Form (ICIQ-UI-SF) was used to investigate primary outcome; new onset UI, and secondary outcome; ICIQ-UI-SF sum score. Suissa and Shuster’s exact unconditional test was used to analyze difference in new onset UI. Difference in ICIQ-UI-SF sum score is presented as mean with 95% CI. Results At baseline 40 out of 128 (31.2%) participants reported UI. Three out of 27, 2 out of 17, 2 out of 23, and 0 out of 21 women in the three training and control groups respectively had new onset UI. There were no statistically significant differences in new onset UI across the groups or when collapsing new onset UI in the intervention groups compared with the controls (7 out of 67 vs 0 out of 21), p = 0.124. After the intervention the control group reported worse ICIQ-UI-SF sum score than any of the training groups; mean difference − 6.6 (95% CI: −11.9, −1.27), p = 0.012, but there was no difference in change from baseline to 12 weeks between the groups p = 0.145). Conclusions There was no statistically significant change in UI after strength training.

The Effectiveness of Locomotor Therapy Using Robotic-assisted Gait Training in Subacute Stroke Patients: A Randomized Controlled Trial

PM&R ◽  
2009 ◽  
Vol 1 ◽  
pp. S99-S99 ◽  
Author(s):  
Zeev Meiner ◽  
Iris Fisher ◽  
Michal Katz-Leurer ◽  
Martin Neeb ◽  
Anna Sajin ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Gait Training ◽  
Stroke Patients ◽  
Robotic Assisted ◽  
Randomized Controlled ◽  
Subacute Stroke

Cluster Symptoms Reduction via Telephone-Based Intervention in Thai Breast Cancer Patients Undergoing 4-Cycle Adjuvant Chemotherapy: A Randomized-Controlled Trial

2021 ◽  
Vol 104 (6) ◽  
pp. 887-894
Keyword(s):  
Breast Cancer ◽  
Randomized Controlled Trial ◽  
Adjuvant Chemotherapy ◽  
Energy Conservation ◽  
Cancer Patients ◽  
Controlled Trial ◽  
Control Group ◽  
Breast Cancer Patients ◽  
Randomized Controlled ◽  
Experimental Group

Background: Cluster symptoms are a common occurrence in breast cancer patients undergoing chemotherapy. The telephone is a well-recognized, convenient device for reaching out to patients for monitoring and managing their symptoms in an efficient, prompt, and appropriate manner. Objective: To investigate the efficacy of telephone-based intervention to achieve energy conservation among breast cancer patients with the aim of alleviating fatigue, pain, sleep disturbance, and depression. Materials and Methods: The present study was a two-armed, randomized control trial conducted in the university hospital between March and September 2019. Seventy-four breast cancer patients, receiving four courses of adjuvant chemotherapy, were randomly recruited and assigned into the experimental group and the control group. One face-to-face intervention interview for energy conservation was conducted, followed by 20-minutes telephone brief counselling and assessment sessions, scheduled on day 1, 2, 7, and 14. Results: The scores for symptoms of median fatigue and pain in the experimental group were shown to be significantly reduced at the end of the study as compared to those scores within the control group (p<0.05). Similarly, scores for median sleep time and depression were greater at the end of cycle 1 and highest in cycle 2 (p<0.05, 0.001, respectively). Physical activity levels were also higher in the experimental group than in the control group in every cycle, with a statistical significance (p<0.001). Conclusion: The present study intervention demonstrated an effectiveness for the reduction of cluster symptoms. Further studies would be needed in a larger population scale in the customary, randomized controlled trial manner. Keywords: Cancer; Energy conservation; Fatigue; Pain; Sleep; Telephone

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